Disabilities rating schedule: Respirator and cardiovascular conditions; evaluation of hypertension with heart disease,
[Federal Register: September 6, 2006 (Volume 71, Number 172)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 4
Schedule for Rating Disabilities; Guidelines for Application of Evaluation Criteria for Certain Respiratory and Cardiovascular Conditions; Evaluation of Hypertension With Heart Disease
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
SUMMARY: This document amends the Department of Veterans Affairs (VA) Schedule for Rating Disabilities by adding guidelines for the evaluation of certain respiratory and cardiovascular conditions and by explaining that hypertension will be evaluated separately from hypertensive and other types of heart diseases.
DATES: Effective Date: This amendment is effective October 6, 2006.
Applicability Date: The provisions of this final rule shall apply to all applications for benefits received by VA on or after the effective date of this final rule.
FOR FURTHER INFORMATION CONTACT: Maya Ferrandino, Consultant, Regulations Staff (211D), Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Ave., NW., Washington, DC 20420, (202) 273-7211.
SUPPLEMENTARY INFORMATION: On August 22, 2002, VA published in the Federal Register (67 FR 54394) a proposal to amend those portions of the Schedule for Rating Disabilities that address cardiovascular and respiratory conditions by providing guidelines for the evaluation of these conditions and by explaining that hypertension will be evaluated separately from hypertensive and other types of heart diseases. Interested persons were invited to submit written comments on or before October 21, 2002. We received a combined comment from the American College of Chest Physicians, the American Thoracic Society, and the National Association for Medical Direction of Respiratory Care.
VA currently uses the ratio of FEV-1 (Forced Expiratory Volume in one second) to FVC (Forced Vital Capacity), or FEV-1/FVC ratio, to evaluate certain respiratory conditions. Proposed 38 CFR 4.96(d)(7) would direct raters to consider a decreased FEV-1/FVC ratio to be normal if the FEV-1 is greater than 100 percent. The rationale was that in that case the FVC would also be high (better than normal), so a decreased ratio would not indicate pathology. The commenter suggested that we not use the ratio but, rather, use 100 percent of predicted value. Because a decreased ratio could indicate pathology, but not disability, the commenter suggested we delete the statement in the preamble to the proposed rule that a decreased ratio is not indicative of pathology. Because the statement noted by the commenter was not part of the proposed regulatory language, but was made in the preamble to the proposed rule, it would have had no regulatory effect. Nevertheless, we agree with the rationale of this suggestion. Therefore, we will address the commenter's suggestion by changing the regulatory language in Sec. 4.96(d)(7) to the following: ``If the FEV- 1 and the FVC are both greater than 100 percent, do not assign a compensable evaluation based on a decreased FEV-1/FVC ratio.''
Chronic bronchitis (diagnostic code 6600), pulmonary emphysema (diagnostic code 6603), chronic obstructive pulmonary disease (diagnostic code 6604), interstitial lung disease (diagnostic codes 6825-6833), and restrictive lung disease (diagnostic codes 6840-6845) are evaluated primarily on the basis of pulmonary function tests (PFT's). However, these conditions may also be evaluated based on alternative evaluation criteria, which may include measures of the maximum exercise capacity; the presence of pulmonary hypertension (documented by echocardiogram or cardiac catheterization), cor pulmonale, or right ventricular hypertrophy; episode(s) of respiratory failure; and a requirement for outpatient oxygen therapy. For example, a 100-percent evaluation for these conditions may be based on a maximum exercise capacity test result of less than 15 ml/kg/min oxygen consumption (with cardiac or respiratory limitation), and a 60-percent evaluation may be based on a maximum exercise capacity test result of 15 to 20 ml/kg/min oxygen consumption (with cardiac or respiratory limitation). We proposed that PFT's be required to evaluate this group of respiratory conditions except, among other exceptions, when the results of a maximum exercise capacity test are of record and are 20 ml/kg/min or less. We also proposed that if a maximum exercise capacity test is not of record, the veteran's disability evaluation would be based on alternative criteria. The commenter stated that since most of the patients with these respiratory conditions have a low exercise tolerance, using the results of only effort-dependent tests would make it easy for some marginal patients to qualify for compensation for their respiratory condition. The commenter stated that exercise tests should be considered maximal and should be performed after PFT results do not fully explain symptomatology.
The vast majority of veterans with respiratory diseases are evaluated on the basis of PFT results. Since the disability due to respiratory disease in veterans ranges from minimal to very severe, and veterans of all ages and all degrees of physical conditioning undergo examinations for respiratory disability, it would be speculative to say that most have a low exercise tolerance. The regulations do not require that a maximum exercise capacity test be conducted in any case, and it is not routinely conducted. If there is already a maximum exercise capacity test of record, and the results are 20 ml/kg/min or less, evaluation (at a 60- or 100-percent level, depending on the exact results) may be based on these results. If no maximum exercise capacity test is of record, as would be true in most cases, this regulation directs that evaluation be based on the alternative criteria. In any given case, the examiner may request, based on clinical judgment, that a maximum exercise capacity test be conducted, such as in cases where the PFT's do not fully explain symptomatology. However, the maximum exercise capacity test is not available in some medical facilities, and evaluation will properly be based in some cases on the clinician's assessment of severity based on history, physical findings, and available laboratory tests. We therefore make no change based on this comment.
The commenter stated that the diagnostic codes in the VA rating schedule for the listed conditions in the proposed rule were confusing and suggested that VA use the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnostic coding system that is used throughout the United States in the health care delivery system. For several reasons, we believe that using ICD-9-CM codes is not a reasonable option.
First, ICD-9-CM and the VA rating schedule serve very different purposes. The ICD-9-CM is used by medical professionals in diagnosing medical conditions. The rating schedule is used by VA personnel in assigning evaluations to conditions that have been diagnosed by medical professionals for VA compensation purposes. The rating schedule is not simply a listing of conditions and symptoms. It includes evaluation criteria for each of the more than 700 disabilities listed. VA also rates disabilities not listed in the rating schedule to the most analogous disability that is listed there. Also, despite its length, the ICD-9-CM does not include certain conditions that VA must commonly evaluate, such as specific muscle injuries. For example, the criteria under diagnostic code 5301 in the rating schedule govern the evaluation of injuries to muscle group I (trapezius, levator scapulae, and serratus magnus). There are 23 muscle groups listed in the VA rating schedule that govern the evaluation of injuries to those muscle groups, and each of the 23
muscle groups has its own set of evaluation criteria based on the severity of the injuries affecting specific muscle functions. Six of them refer to various muscle injuries of the shoulder and upper arm. In contrast, ICD-9-CM code 959.2 covers injuries to the axilla and scapular region of the ``Shoulder and upper arm,'' which is as specific as ICD-9-CM gets for these injuries. Over 350,000 veterans are currently evaluated under VA's muscle injury criteria, which are commonly used for evaluating residuals of combat injuries, such as gunshot and shell fragment wounds. Such VA diagnostic codes are therefore of great importance to VA in evaluating veterans with combat wounds, and also provide useful information for statistical purposes.
Other problems would arise from replacing VA's diagnostic codes with the ICD-9-CM codes. ICD-9-CM's high level of specificity for some conditions would make use by raters difficult, since in some cases a specific code would apply, while in others only the general code would be required for rating purposes. Another issue is that VA has special codes for certain combined disabilities--loss or loss of use of an arm and loss or loss of use of a leg, for example--which have special significance for VA rating purposes, but which have no equivalent in ICD-9-CM. For these reasons, VA does not believe that using ICD-9-CM codes to indicate veterans' disabilities for purposes of compensation would be feasible or useful. We therefore make no change based on this comment.
VA appreciates the comment submitted in response to the proposed rule. Based on the rationale stated in the proposed rule and in this document, the proposed rule is adopted with the changes noted.
Paperwork Reduction Act
This document contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3521).
Regulatory Flexibility Act
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601- 612. The reason for this certification is that this amendment would not directly affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
Executive Order 12866
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: Having an annual effect on the economy of $100 million or more, creating a serious inconsistency or interfering with an action of another agency, materially altering the budgetary impact of entitlements or the rights of entitlement recipients, or raising novel legal or policy issues. This document has been reviewed by the Office of Management and Budget under Executive Order 12866.
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector.
Catalog of Federal Domestic Assistance Numbers
The Catalog of Federal Domestic Assistance program numbers and titles for this proposal are 64.104, Pension for Non-Service- Connected Disability for Veterans, and 64.109, Veterans Compensation for Service-Connected Disability.
List of Subjects in 38 CFR Part 4
Disability benefits, Pensions, Veterans.
Approved: May 26, 2006. Gordon H. Mansfield, Deputy Secretary of Veterans Affairs.
0 For the reasons set out in the preamble, 38 CFR part 4, subpart B, is amended as set forth below:
PART 4--SCHEDULE FOR RATING DISABILITIES
Subpart B--Disability Ratings
0 1. The authority citation for part 4 continues to read as follows:
Authority: 38 U.S.C. 1155, unless otherwise noted.
0 2. Section 4.96 is amended by adding paragraph (d) to read as follows:
Sec. 4.96 Special provisions regarding evaluation of respiratory conditions.
* * * * *
(d) Special provisions for the application of evaluation criteria for diagnostic codes 6600, 6603, 6604, 6825-6833, and 6840-6845.
(1) Pulmonary function tests (PFT's) are required to evaluate these conditions except:
(i) When the results of a maximum exercise capacity test are of record and are 20 ml/kg/min or less. If a maximum exercise capacity test is not of record, evaluate based on alternative criteria.
(ii) When pulmonary hypertension (documented by an echocardiogram or cardiac catheterization), cor pulmonale, or right ventricular hypertrophy has been diagnosed.
(iii) When there have been one or more episodes of acute respiratory failure.
(iv) When outpatient oxygen therapy is required.
(2) If the DLCO (SB) (Diffusion Capacity of the Lung for Carbon Monoxide by the Single Breath Method) test is not of record, evaluate based on alternative criteria as long as the examiner states why the test would not be useful or valid in a particular case.
(3) When the PFT's are not consistent with clinical findings, evaluate based on the PFT's unless the examiner states why they are not a valid indication of respiratory functional impairment in a particular case.
(4) Post-bronchodilator studies are required when PFT's are done for disability evaluation purposes except when the results of pre- bronchodilator pulmonary function tests are normal or when the examiner determines that post-bronchodilator studies should not be done and states why.
(5) When evaluating based on PFT's, use post-bronchodilator results in applying the evaluation criteria in the rating schedule unless the post-bronchodilator results were poorer than the pre-bronchodilator results. In those cases, use the pre-bronchodilator values for rating purposes.
(6) When there is a disparity between the results of different PFT's (FEV-1 (Forced Expiratory Volume in one second), FVC (Forced Vital Capacity), etc.), so that the level of evaluation would differ depending on which test result is used, use the test result that the examiner states most accurately reflects the level of disability.
(7) If the FEV-1 and the FVC are both greater than 100 percent, do not assign
a compensable evaluation based on a decreased FEV-1/FVC ratio. * * * * *
0 3. Section 4.100 is added to read as follows:
Sec. 4.100 Application of the evaluation criteria for diagnostic codes 7000-7007, 7011, and 7015-7020.
(a) Whether or not cardiac hypertrophy or dilatation (documented by electrocardiogram, echocardiogram, or X-ray) is present and whether or not there is a need for continuous medication must be ascertained in all cases.
(b) Even if the requirement for a 10% (based on the need for continuous medication) or 30% (based on the presence of cardiac hypertrophy or dilatation) evaluation is met, METs testing is required in all cases except:
(1) When there is a medical contraindication.
(2) When the left ventricular ejection fraction has been measured and is 50% or less.
(3) When chronic congestive heart failure is present or there has been more than one episode of congestive heart failure within the past year.
(4) When a 100% evaluation can be assigned on another basis.
(c) If left ventricular ejection fraction (LVEF) testing is not of record, evaluate based on the alternative criteria unless the examiner states that the LVEF test is needed in a particular case because the available medical information does not sufficiently reflect the severity of the veteran's cardiovascular disability.
0 4. Section 4.104, diagnostic code 7101 is amended by adding a Note (3) to read as follows:
Sec. 4.104 Schedule of ratings--cardiovascular system.
* * * * *
7101 * * *
Note (3): Evaluate hypertension separately from hypertensive heart disease and other types of heart disease.
* * * * * [FR Doc. E6-14732 Filed 9-5-06; 8:45 am]
BILLING CODE 8320-01-P